US and European regulators accept AstraZeneca's cancer drug applications

The US FDA has accepted AstraZeneca’s biologics licence application for Moxetumomab Pasudotox while the European Medicines Agency will review the company's marketing authorisation application for Lynparza

Lynparza is used to treat patients who have metastatic breast cancer

US and European regulators have accepted applications for AstraZeneca PLC ‘s (LON:AZN) cancer treatments Moxetumomab Pasudotox and Lynparza .

AstraZeneca said the US Food and Drug Administration (FDA) has accepted the biologics license application for Moxetumomab Pasudotox, used to treat hairy-cell leukaemia in adults.

READ: AstraZeneca pushes back timeline for MYSTIC phase III lung cancer clinical trial

The FDA has also granted the medicine priority-review status.

The European Medicines Agency will review AstraZeneca’s marketing authorisation application for Lynparza, representing the first regulatory submission for a poly ADP-ribose polymerase inhibitor for breast cancer in Europe.

Lynparza is used for patients who have metastatic breast cancer and have been treated with chemotherapy.

Shares in AstraZeneca fell 0.7% to 4,858p in morning trading.


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